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The ILI nebulizer is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and healthcare settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer is disposable, single-patient-use and intended for use with pediatric (5 years and older) and adult patient.

The JLI nebulizer is a small volume jet nebulizer designed to deliver aerosolized medications for inhalation to the respiratory system, the compressed air is forced into the nebulizer through a nozzle cover, where it accelerates and emerges at a high velocity, creating a vacuum (Venturi effect), in the process the liquid medicine is converted into small droplets called aerosol by impacting upon a rigid baffle, the aerosol may be used for inhalation treatment of a physician's prescription. The JLI nebulizer is disposable, single-patient-use.

The provided text describes the 510(k) premarket notification for the JLI nebulizer, asserting its substantial equivalence to a predicate device (BESMED Jet Nebulizer Bottle Set). However, it does not contain information about an AI/ML-driven medical device. The document details the non-clinical performance and biocompatibility testing of a nebulizer, a hardware device used to administer aerosol treatments.

Therefore, I cannot extract the requested information about acceptance criteria, study design, ground truth establishment, or expert involvement as these details are specific to the evaluation of AI/ML software performance, not hardware nebulizers.

The document discusses:

• Acceptance Criteria for the Nebulizer: This is implied through the comparison of aerosol particle characteristics (MMAD, GSD, Respirable fraction, Total dose) between the JLI nebulizer and the predicate device. The goal is to show "not significant statistical difference" and "substantial equivalence."
• Performance Study: Non-clinical tests were conducted for aerosol characterization using three drugs (Albuterol sulfate, Ipratropium bromide, Budesonide) at two sampling rates (28 L/min and 12 L/min).
• Sample Size for Test Set: For aerosol characterization, the data shows means and standard deviations, implying multiple runs for each drug and sampling rate. For example, for Albuterol sulfate at 28 L/min, the data 7.4990±0.5384 indicates a sample size was used to calculate the mean and standard deviation. While the exact number of runs isn't explicitly stated as "N=X", it's implied that there were sufficient runs to provide statistical averages.
• Data Provenance: The tests were non-clinical, likely performed in a lab setting by the manufacturer or a contracted lab. The document does not specify country of origin for the performance data beyond the manufacturer being in China. It is explicitly stated that "Substantial equivalence does not depend on clinical test data," meaning no patient data was used.
• Ground Truth: For aerosol characterization, the 'ground truth' is the quantitative measurements of aerosol properties (MMAD, GSD, etc.) obtained through validated laboratory testing methods (e.g., in accordance with USP 40 Aerosols, Nasal Sprays, Metered-Dose Inhalers, and Dry Powder Inhalers). There are no human experts, adjudication, or MRMC studies involved because it's a hardware performance test, not an AI diagnostic tool.
• Training Set: Not applicable, as this is a hardware device, not an AI/ML algorithm.

In summary, the provided document does not pertain to an AI/ML device and thus the specific questions about AI/ML acceptance criteria and study design elements (like expert readers, MRMC, training sets, etc.) cannot be answered from this text.

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The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) include an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatic patients (4 years and older).

The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic) nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device.

When the compressor is used in conjunction with a therapeutic nebulizer set, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.

The provided document is a 510(k) summary for the JLN-23XX Series Piston Compress Nebulizer. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study involving an AI/Machine Learning device or a study comparing human readers with and without AI assistance.

The "device" in question is a physical nebulizer, not an AI or software algorithm. The "acceptance criteria" and "device performance" discussed refer to the physical and electrical specifications of the nebulizer and its ability to aerosolize drugs, demonstrated through laboratory testing.

Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the device described in this document.

The document focuses on demonstrating substantial equivalence for a physical medical device (nebulizer) based on:

• Identical Indications for Use: Both the proposed and predicate devices are used to convert inhalable drugs into aerosol form for inhalation by adult and pediatric patients (4 years and older).
• Similar Technological Characteristics: The comparison table (Table 1) highlights similar compressor type (piston), electrical requirements, operating conditions (temperature, humidity), and various performance parameters like flow rate, max pressure, and noise level.
• Non-Clinical Bench Testing: The non-clinical tests specifically verify the device's electrical safety (IEC 60601-1, IEC 60601-1-2), EMC protection, noise, pressure, flowrate, and biocompatibility. Crucially, a particle size distribution test was performed to compare the proposed device's aerosol output with that of the predicate device, demonstrating equivalent performance.
• No Clinical Tests Performed: The document explicitly states "Not Applicable" for clinical tests, which is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.

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